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A Trial Investigating the Relationship Between Pharmacodynamic and Interstitial Concentration for Insulin Detemir and Human Insulin

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ClinicalTrials.gov Identifier: NCT02162407
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Europe. The aim of this study is to estimate the relationship between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous (i.v.) administration of insulin detemir and human soluble insulin.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: insulin detemir Drug: human soluble insulin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Three-period Crossover Trial in Healthy Subjects Investigating the Relationship Between the Pharmacodynamic Steady State and the Pharmacokinetic Steady State in the Interstitial Fluid Following iv Infusion of Insulin Detemir and Human Insulin Using Microperfusion Technique
Study Start Date : October 1999
Actual Primary Completion Date : December 1999
Actual Study Completion Date : December 1999

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin detemir 60 pmol/kg/min
Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order)
Drug: insulin detemir
Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp

Experimental: Insulin detemir 120 pmol/kg/min
Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order)
Drug: insulin detemir
Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp

Active Comparator: Human insulin 6 pmol/kg/min
Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order)
Drug: human soluble insulin
Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp




Primary Outcome Measures :
  1. Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration [ Time Frame: 8 hours ]

Secondary Outcome Measures :
  1. Steady state glucose infusion rate (GIR) [ Time Frame: 8 hours ]
  2. Steady state insulin interstitial concentration [ Time Frame: 8 hours ]
  3. Ratio of steady state serum insulin concentration to interstitial insulin concentration [ Time Frame: 8 hours ]
  4. Insulin concentration profiles [ Time Frame: 8 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy males between 19 and 50 years inclusive
  • The subject must give signed informed consent before any trial related activity. (Trial related activities are any procedures that would not have been performed during the normal management of the subject)
  • Body Mass Index (BMI) below 27 kg/m^2
  • Fasting blood glucose maximum 6 mmol/l

Exclusion Criteria:

  • Participation in any other clinical trial involving other investigational products within the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162407


Locations
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Austria
Graz, Austria, 8036
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02162407    
Other Study ID Numbers: NN304-1196
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs